Tagged with ARM

Pharma Legal Handbook Are biosimilar medicines considered the same as generic medicines in your country? In Egypt, Biosimilars are considered different from Generic Medicines but similar to biological products, where the “Biosimilar” definition according to the Guidelines for Registration of biosimilar products in Egypt, is the following: A similar biological medicinal product having…

Pharma Legal Handbook Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Yes, the legal framework of localization is regulated through Ministerial Decree No. 296 of 2009, No. 425 of the year 2015, Ministerial Decree No. 820 of…

Pharma Legal Handbook What is the definition of Rare Diseases in your country? In Egypt, there is no definition of the “Rare Diseases” however, in accordance with the conclusion of medicine professors’ researches and studies a disease is considered a rare disease if it affects 1 in 2,000 or 2,500 individuals.   Does…

Pharma Legal Handbook   What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Thailand, drugs, biologics, and medical devices are regulated by the Thai Food and Drug Administration (Thai FDA), under the supervision of the Ministry of Public Health (MOPH). More precisely, the Drug Division…

Pharma Legal Handbook Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, the clinical trial does not need to be conducted locally in order to obtain marketing approval. The Thai FDA only requests that clinical data be arranged in either the format of Part…

Pharma Legal Handbook What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Pharmaceutical Products The authorization processes for the marketing of new drugs, biologics, over-the-counter medications, and other medicinal products are the same. Companies and individuals that wish to place a drug…

Pharma Legal Handbook What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In April 2019, the Thai FDA published and implemented the Herbal Product Act. This is now the main act regulating herbal or traditional medicine in Thailand. The authorization process for the marketing of traditional medicines and…

Pharma Legal Handbook What types of liability are recognized in your jurisdiction? The laws of Thailand provide for civil, criminal, and administrative liabilities. Fundamentally, product liability is recognized as part of sales and contract law wherein the seller shall be liable to the buyer for a damage caused by deficient goods. This liability…

Pharma Legal Handbook What are the basic requirements to obtain patent and trademark protection? Patent The “subject matter” contained in a patent application may be patented if the following requirements are met: Novelty: Before the filing date, the subject matter must not have been publicly used anywhere in Thailand, and the details of…

Pharma Legal Handbook Are there proposals for reform or significant change to the healthcare system? Significant changes to the healthcare system include the following: The Patent Act The Patent Act is currently under review and final revision by the Department of Intellectual Property, and is expected to be passed soon. The Act’s amendments…

Pharma Legal Handbook Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Yes. Pursuant to Section 12 of the Drug Act 1967, as amended, any domestic manufacturing, importing or ordering into Thailand, including the distributing of active pharmaceutical…

Pharma Legal Handbook Chapter 9: Cannabinoid Drugs Are Cannabinoid Drugs authorized in your country? For the purpose of this chapter, cannabinoid drugs are drugs containing a cannabinoid, which may be extracted and purified from a cannabis plant or synthesized by other means without involving a cannabis plant. The formulations of cannabinoid drugs may…